Welcome to our dedicated page for Genmab news (Ticker: GMAB), a resource for investors and traders seeking the latest updates and insights on Genmab stock.
Genmab A/S (GMAB) generates frequent news flow as an international biotechnology company focused on antibody medicines for cancer and other serious diseases. Company announcements highlight advances in its antibody platforms, late‑stage clinical programs, regulatory milestones and corporate transactions, offering investors and observers a detailed view of how its science translates into clinical and commercial progress.
Recent news has emphasized the expanding clinical profile of epcoritamab (EPKINLY), an IgG1‑bispecific antibody created using Genmab’s DuoBody technology. Genmab regularly reports data from Phase 1b/2 and Phase 3 trials in diffuse large B‑cell lymphoma, follicular lymphoma and Richter transformation, including monotherapy and combination regimens with standard treatments such as R‑CHOP, R‑mini‑CHOP, rituximab and lenalidomide, and bendamustine plus rituximab. These updates often include response rates, survival outcomes and safety findings from major oncology congresses.
News coverage also includes developments in Genmab’s wholly owned pipeline, such as updated data for rinatabart sesutecan (Rina‑S) in advanced endometrial cancer and the expansion of its clinical program into Phase 3 trials. Corporate strategy items, including the planned acquisition and subsequent tender offer for Merus N.V. to add petosemtamab to the portfolio, feature prominently in company announcements and SEC‑related communications.
In addition, Genmab reports on initiatives that shape how it conducts research and development, such as its partnership with Anthropic to deploy Claude‑powered agentic AI solutions to support clinical development operations. Visitors to this GMAB news page can review these company announcements, trial readouts, regulatory updates and transaction disclosures to follow how Genmab’s antibody platforms, collaborations and late‑stage assets evolve over time.
TIVDAK® (tisotumab vedotin) has received approval from Japan's Ministry of Health, Labour and Welfare for treating advanced or recurrent cervical cancer that has progressed after chemotherapy. This marks a significant milestone as TIVDAK becomes the first and only antibody-drug conjugate (ADC) approved for cervical cancer patients in Japan.
The approval is supported by the global Phase 3 innovaTV 301 trial results, which demonstrated superior overall survival compared to chemotherapy. The study showed a 30% reduction in risk of death, with median overall survival of 11.5 months for TIVDAK versus 9.5 months for chemotherapy. The trial included 502 patients, with 101 being Japanese.
Common adverse reactions, observed in 87.6% of 250 treated patients, included conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%).
Genmab A/S (GMAB) reported updated data from Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), showing promising results in treating advanced ovarian cancer. With a median follow-up of 48 weeks, Rina-S at 120 mg/m2 demonstrated:
- Confirmed objective response rate (ORR) of 55.6%
- Disease control rate (DCR) of 88.9%
- Median duration of response (mDOR) not reached
- Complete responses in 4 patients (2 confirmed, 2 unconfirmed)
- Confirmed partial responses in 8 patients (44.4%)
At 100 mg/m2, the study showed a 22.7% ORR and 86.4% DCR. Common side effects included anemia, nausea, and neutropenia. The 120 mg/m2 dose has been selected for further evaluation in ongoing Phase 2 RAINFOL-01 and Phase 3 RAINFOL-02 trials for platinum-resistant ovarian cancer (PROC).
Genmab (Nasdaq: GMAB) announced that Johnson & Johnson (J&J) has declined to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38. Following this decision and a portfolio evaluation, Genmab will discontinue further clinical development of the drug.
The Phase 2 expansion study comparing HexaBody-CD38 with DARZALEX FASPRO® in multiple myeloma patients showed an overall response rate (ORR) of 55% for HexaBody-CD38 versus 52% for daratumumab. Very good partial response rates were 29% vs. 17%, and complete response rates were 7% vs. 2%. Common treatment emergent adverse events included neutropenia, infusion-related reactions, anemia, and thrombocytopenia.
Despite promising clinical data validating the HexaBody platform's potential, Genmab will focus on its existing pipeline, including EPKINLY® and two wholly owned assets in Phase 3 development: rinatabart sesutecan and acasunlimab. The company maintains its 2025 Financial Guidance.
Genmab A/S (Nasdaq: GMAB) announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for treating patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior lines of therapy. This approval is based on results from two Phase 1/2 EPCORE® clinical trials, which demonstrated strong and durable efficacy in patients.
EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan to treat both R/R FL and R/R large B-cell lymphomas. FL accounts for 20-30% of non-Hodgkin’s lymphoma (NHL) cases, with approximately 19,000 patients living with FL in Japan. FL is considered incurable with current therapies, and patients often relapse, leading to shorter remission periods.
The approval is supported by data from the EPCORE NHL-1 and EPCORE NHL-3 trials. In the global EPCORE NHL-1 trial, the overall response rate (ORR) was 82%, with a complete response (CR) rate of 62.5%. In the Japanese EPCORE NHL-3 trial, the ORR was 95.2%, with a CR rate of 76.2%. Common adverse events included cytokine release syndrome (CRS) and injection site reactions.
EPKINLY is the only bispecific antibody approved in the U.S., European Union, and Japan for dual indications in treating B-cell malignancies.
Genmab A/S (GMAB) announced new long-term results from two clinical trials evaluating epcoritamab in patients with diffuse large B-cell lymphoma (DLBCL). The EPCORE® NHL-2 trial showed a 100% overall response rate and 87% complete response rate in high-risk patients with previously untreated DLBCL when epcoritamab was combined with R-CHOP therapy. Among complete responders, 83% remained in remission after two years.
In the EPCORE® NHL-1 trial, evaluating epcoritamab monotherapy in relapsed/refractory patients, 41% achieved complete response, with an estimated 52% still responding at three years. The median complete response duration was 36.1 months. Both analyses were presented at the ASH Annual Meeting.
Genmab announced promising results from the Phase 1b/2 EPCORE® CLL-1 trial evaluating epcoritamab in treating relapsed/refractory chronic lymphocytic leukemia (CLL). The trial demonstrated an overall response rate of 61% and a complete response rate of 39% in difficult-to-treat patients. Among evaluable responders, 75% achieved undetectable minimal residual disease.
The study showed median progression-free survival of 12.8 months, with 65% of patients alive at 15 months. The most common side effect was cytokine release syndrome (96%). The trial included heavily pretreated patients with at least four previous therapy lines, showing particularly encouraging results in patients with high-risk factors, including those with TP53 aberrations (67% ORR) and IGHV-unmutated disease (63% ORR).
Genmab A/S (GMAB) announced promising results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating epcoritamab combination therapy in relapsed/refractory follicular lymphoma patients. The study demonstrated remarkable efficacy with a 96% overall response rate and 87% complete response rate among 111 patients after two years median follow-up.
Key outcomes include 80% progression-free survival at 21 months and 90% overall survival rate at two years. The treatment showed durable responses with 89% of complete responders maintaining their response at 18 months. The FDA recently granted breakthrough therapy designation for this combination therapy.
Notable adverse events included neutropenia (62%) and cytokine release syndrome (51%, mostly low-grade). COVID-19 affected 57% of patients, leading to treatment discontinuation in 13% of cases, with five fatal outcomes.
Genmab A/S (GMAB) announced the presentation of over 20 abstracts evaluating epcoritamab-bysp at the 2024 ASH Annual Meeting. The presentations include four oral sessions highlighting data on fixed-duration subcutaneous epcoritamab in various B-cell malignancies. Key presentations will feature data from previously untreated DLBCL, LBCL, relapsed/refractory follicular lymphoma, and chronic lymphocytic leukemia patients. The event will also showcase three-year efficacy and safety data from the EPCORE NHL-1 trial in R/R DLBCL patients. Genmab will host a virtual R&D Update and ASH Data Review on December 11.
Life Science Washington Institute (LSWI) has awarded the 2024 Entrepreneurial Achievement Award to Dr. Baiteng Zhao and Dr. Tae H. Han, co-founders of ProfoundBio. The award recognizes their significant contributions to life science innovations and economic development in Washington state. ProfoundBio, founded in 2020, focused on developing antibody-drug conjugates (ADCs) for cancer treatment. In just four years, the company advanced multiple ADC candidates into clinical trials and secured $250 million in funding, including a $112 million Series B round in February 2024.
ProfoundBio was recently acquired by Genmab A/S (Nasdaq: GMAB) for approximately $1.8 billion in cash, marking one of the top life science deals in 2024. Dr. Zhao and Dr. Han are graduates of LSWI's Washington Innovation Network (WIN) mentoring program, which has supported 102 ventures that have collectively raised over $3.2 billion. The award highlights the success of Washington's life sciences ecosystem in fostering homegrown talent and innovation.
Genmab A/S (Nasdaq: GMAB) announced promising results from a Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted antibody-drug conjugate for ovarian cancer. The study showed a 50% confirmed objective response rate in patients treated with Rina-S 120 mg/m2 every 3 weeks, regardless of FRα expression levels. Key findings include:
- 95% of patients in the 120 mg/m2 group had platinum-resistant ovarian cancer
- 50% ORR for 120 mg/m2 vs 18.2% for 100 mg/m2
- 88.9% disease control rate for 120 mg/m2
- All confirmed responses ongoing at data cutoff
Based on these results, Rina-S 120 mg/m2 will be evaluated in a Phase 3 trial for advanced ovarian cancer, expected to start in 2024. Common side effects included anemia, neutropenia, and nausea, with infrequent dose reductions or discontinuations.